Real World Data (RWD) are data used for decision making that are not collected in conventional randomised controlled trials (RCTs). Real World Evidence (RWE) is the evidence generated from RWD. A linked concept is ‘Big Data,’ which is generated from combing multiple sources of RWD. At the heart of RWD and RWE is patient-centricity.
RWD can be clinical, economic and humanistic and come from diverse sources; from patient records to social media and nearly everything in between. However, this proliferation of data also poses challenges for methods and analysis. Further, companies need to keep tabs on RWD and RWE in their fields as, even if they are not generating this data, others might release findings that necessitate a company response.
Real World Data and Real World Evidence for Market Access
Interest in RWD and RWE is increasing, with various stakeholders – including companies, regulators, Health Technology Assessment (HTA) agencies, payers, providers and patients – leveraging the information to inform their decisions. This data is proving particularly relevant to some HTA agencies and payers as they focus on therapies that provide value for money.
RWD and RWE are increasingly being seen as an enabler for market access, with case studies emerging on how RWD and RWE can ‘tip the balance’ from a no to a yes with HTA agencies, including the Scottish Medicines Consortium (SMC), the National Institute for Health and Care Excellence (NICE) and the French Authority for Health (HAS). However, RWD and RWE may need to be coupled with changes in price to secure those positive recommendations. Acceptance of RWD and RWE across agencies is not universal and challenges to using RWD and RWE with payers need to be overcome to increase their influence.